# K101491: Uroskop Omnia

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 30, 2010 after 29 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K801623 (1980). 57 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010942: U04, Siemens Medical Solutions USA, Inc. (2001) Summary page 3.
- K062623: Axiom Luminos DRF, Siemens Medical Solutions USA, Inc. (2007) Summary page 2.

## Most influential descendants
- K122768: Genesis (2013), 4 descendants of its own
- K161019: Uroview FD (2016), 2 descendants of its own
- K133434: Genesis II (2014), 2 descendants of its own
- K173639: Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax (2018), 1 descendant of its own
- K151485: Genesis (2015), 1 descendant of its own

## Recalls of this device
- Jun 4, 2025 · Class II · Z-1982-2025: A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
- Jun 4, 2025 · Class II · Z-1981-2025: A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
- Sep 9, 2020 · Class II · Z-0805-2021: After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long pe
- Feb 8, 2019 · Class II · Z-0984-2019: The swivel arm holding the monitors may become dislodged from the carrying arm.
- Apr 13, 2015 · Class II · Z-1670-2015: Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image rec
- Sep 2, 2014 · Class II · Z-0004-2015: Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers 
- Jul 7, 2014 · Class II · Z-2292-2014: It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunct
- Sep 3, 2013 · Class II · Z-0140-2014: When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is no
- Sep 3, 2013 · Class II · Z-0374-2014: A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing lo
- Aug 28, 2013 · Class II · Z-1845-2014: When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repetition of the examinat
- May 6, 2013 · Class II · Z-0016-2014: Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exis
- Feb 15, 2012 · Not classified · Z-1159-2012: Firm has become aware of unintended behavior when using Ysio, AXIOM dRF, AXIOM Luminos Agile/TF and Uroskop Omnia with RAD Fluoro Uro function using software version VC10A. Due to an error in the imag

## Indications for use
The UROSKOP Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including: Querying and retrieving patient history information and/or previous diagnosis and images from other modalities. X-ray examinations of the urogenital and area (e.g. cystoscopy, kidney, bladder, urecter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and micturation cystourethrogram combined with uroflow measurements. Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of the kidncy, bladder, prostate, scrotum. endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH, brachytherapy, as well as gynecological procedures requiring radiological suppert). percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy) laparoscopy (e.g. cholecystectomy, nephrectomy, lymph node dissection, abdominal testis detection/correction, varicocele). application of fistula (kidney/bladder) simple procedures (e.g. urethra, testis, phimosis) intracorporeal shock wave lithotripsy uroflow/urodynamics pediatric radiological and therapeutic applications.

Source page: https://510kreport.com/device/K101491
Methodology: https://510kreport.com/methodology